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Levofloxacin Inhalation Solution (Aeroquinâ?¢) compared to placebo in people with Cystic Fibrosis

Study Type:

Interventional

Intervention Category:

Anti-Infective

Study Sponsor:

Mpex

Study Phase:

3

Recruitment Status:

Trial Completed

Study Drug(s):

Levofloxacin (Inhaled)

Number of Participants Being Recruited:

330

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

People with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. This study is a phase 3 placebo controlled trial that will look at the safety and effectiveness of an aerosolized form of the antibiotic, levofloxacin (AEROQUINâ?¢) , when given twice a day over 28 days. Clinical trial participants will receive either an aersolized placebo solution or the aersolized levofloxacin, Aeroquinâ?¢.

ELIGIBILITY

Age:

>= 12 Years

FEV1:

25 - 85 Percent Predicted

P. aeruginosa status:

Positive

B. cepacia status:

Not applicable

Other Primary Eligibility Requirements:

Participants in the MPEX 204 study are not eligible for this study.

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.

The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.